Trialign SCOUT I Study for Tricuspid Repair to Be Presented at TCT 2016

SCOUT I is the first clinical study to report 30-day subject data examining transcatheter tricuspid repair in the United States.

TEWKSBURY, Mass.--()--Mitralign will present data on its Trialign™ Tricuspid Repair system at the TCT conference which will be held in Washington, DC on October 29 through November 2. The company will be presenting 30 Day data from SCOUT I, a U.S. multi-center, Early Feasibility Study (EFS).

“We are excited to present data from the first clinical investigation in the United States on transcatheter tricuspid therapy. The 30 Day SCOUT I data establishes Trialign as one of the most promising solutions for patients with tricuspid disease,” said Rick Geoffrion, chief executive officer of Mitralign.

The 30-day data will be presented by Dr. Rebecca Hahn on Tuesday November 1 at 8:29 AM in the Walter E. Washington Convention Center, Presentation Theater 2, Hall A, Lower Level in the presentation Early Feasibility of a Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation: 30-Day Results From the SCOUT Trial.

The company will host a sponsored symposium, TRIALIGN: The New Era of Tricuspid Repair, on October 30 from 11:30 AM-12:30 PM in Walter E. Washington Convention Center, Room 209, Level 2. The faculty include Martin Leon, MD, Rebecca T. Hahn, MD, Azeem Latib, MD, Scott Lim, MD, Gorav Ailawadi, MD, Charles Davidson, MD, Christopher Meduri, MD and Joachim Schofer, MD.

Additional information on the Trialign System may be obtained by visiting the Mitralign booth, 1537.

About Tricuspid Regurgitation (TR)
Tricuspid regurgitation occurs when the tricuspid valve fails to open and close properly, causing blood to flow backwards into the right atrium. If left untreated, TR can lead to heart enlargement and heart failure. In the U.S. alone, there are an estimated 1.6 million patients suffering from TR1.

It is estimated that 50% of patients with mitral regurgitation have moderate to severe tricuspid regurgitation2. The annual incidence of patients with TR is increasing with an estimated 220,000 patients in the US, and 330,000 patients in the EU developing moderate-severe TR each year3.

Despite the large prevalence of patients, TR is generally untreated by surgery with approximately 10,000 tricuspid valve surgeries performed annually in the US4. Annuloplasty repair is the most used technique for tricuspid valve surgery and represents 90% of the current volume. Isolated tricuspid valve surgery is particularly rare representing only 10% of current procedures while the remaining 90% are performed in conjunction with other left-heart surgeries4, 5.

About Mitralign Inc.
Mitralign Inc. is the valve repair company with the only direct transcatheter annuloplasty system designed to treat both functional mitral regurgitation and tricuspid regurgitation. The company is a venture-backed, medical innovation company located near Boston, Massachusetts, USA. The Trialign System is an investigational device and is limited by Federal (or United States) Law to investigational use. The Mitralign Percutaneous Annuloplasty System (MPAS) received CE mark approval in February for the treatment of functional mitral regurgitation (FMR) and is not commercially available in the U.S.A. For more information, visit www.mitralign.com.

   
1. Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61
2. Argarwal et al. Circ Cardiovasc Interv 2009;2:565-573
3. Tricuspid Regurgitation Global Strategic Market Assessment. Dymedex Consulting. 2016
4. STS Adult Cardiac Surgery Database Executive Summary. 2014
5. Armen K. et al. Ann Thorac Surg. 2013;96:1546–52
 

Contacts

Mitralign Inc.
David Schleifer, +1 617-869-6166
Vice President of Marketing
dschleifer@mitralign.com

Release Summary

Trialign SCOUT I Study for Tricuspid Repair to be presented at TCT 2016. SCOUT I is the first clinical study to report 30-day subject data examining transcatheter tricuspid repair in the USA.

Contacts

Mitralign Inc.
David Schleifer, +1 617-869-6166
Vice President of Marketing
dschleifer@mitralign.com